Aggrastat

For non-ST elevation acute coronary syndrome (NSTE-ACS). NDA 20912, held by Medicure. Tirofiban Hydrochloride.

As of Nov 14, 2026, NDA 20912 (Aggrastat), held by Medicure, was first approved by FDA on May 14, 1998, with 18 approved supplements and 0 published complete response letters.

First approved: May 14, 1998
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Oct 10, 2013	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 14, 1998	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Products

2 strengths and forms


AggrastatEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) · injectable;injection	Tirofiban Hydrochloride	Discontinued
AggrastatEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) · solution;injection	Tirofiban Hydrochloride	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


May 16, 2019	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 31, 2016	Supplement 24Manufacturing	Approved	Label
Apr 21, 2015	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 10, 2013	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 10, 2013	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 6, 2012	Supplement 18Labeling	Approved	Label Letter
Feb 28, 2003	Supplement 13Labeling · Standard review	Approved	Letter
Jul 24, 2002	Supplement 9Labeling · Standard review	Approved	Letter
Jun 17, 2002	Supplement 12Labeling · Standard review	Approved	Letter
Feb 12, 2002	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 17, 2002	Supplement 10Manufacturing · Priority review	Approved	None posted
Sep 25, 2001	Supplement 8Labeling · Standard review	Approved	Letter
Mar 23, 2001	Supplement 7Labeling · Standard review	Approved	Letter
Feb 8, 2001	Supplement 6Manufacturing · Priority review	Approved	None posted
Dec 15, 2000	Supplement 5Manufacturing · Priority review	Approved	None posted
Jan 11, 2000	Supplement 4Labeling · Standard review	Approved	Review
Jul 9, 1999	Supplement 1Labeling · Standard review	Approved	Review Letter Label
Jun 9, 1999	Supplement 2Labeling · Standard review	Approved	None posted
May 14, 1998	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Identifiers

Application: NDA 20912
Drugs@FDA: Overview at FDA
Company: Medicure

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters